ISO 13485 & EU MDR / IDE Requirements -Process
What is the process to submit an IDE to FDA? Is there an outline/checklist for this process? Please provide information for clarity and understanding.
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ISO 13485 DOCUMENTATION TOOLKIT
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All information regarding the Investigational Device Exemption (IDE) you can find on the following web page: https://www.fda.gov/medical-devices/how-study-and-market-your-device/investigational-device-exemption-ide
If you look at the following chapter, you will find what is the approval process for the IDE:https://www.fda.gov/medical-devices/investigational-device-exemption-ide/ide-approval-process
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